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USD 100 /hr

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Hire ASHOK P.

India

USD 100 /hr

Senior Pharma & Biotech professional with expertise in GMP, QMS, Remediation, new facility concept design & Auditing

Profile Summary

CAREER SUMARY

•	33 Years of broad working experience having worked with different Pharmaceutical, Biopharmaceutical and Vaccine manufacturers covering all therapeutic areas and process steps right from R&D to Distribution and Storage complying with the various GxP regulatory requirements.
•	Expertise in aseptic sterile manufacturing (small volume, large volume and dry powder), but besides this also have worked with other formulation dosage forms such as tablets, capsules, ointments and liquid orals. 
•	Last 20 years have been working in Quality function at Senior to Top Management positions. I had started my career, working in Basic Research & Development for 4 years followed by Production department for 9 years.
•	Have handled the entire gamut of product life cycle from R&D to Distribution.
•	Worked for 6 years with Azbil Telstar, a leading Spanish Pharma Consultancy company in charge for overall quality management activities of the Indian operations for the company
•	As a lead Auditor have performed 180 cGMP audits at various drug substance and drug product manufacturing facilities located in India, China, Japan, S. Korea, Hong Kong, Malaysia, Israel and USA.
•	Expertise in matters of Quality Assurance including design and validation of green field projects, implementation and management of quality systems and obtaining regulatory approvals such as USFDA, MCA, MCC, MHRA and ANVISA.

ACADEMIC QUALIFICATION

Masters in Microbiology                      : - Year 1986 from S.P.University, Gujarat, India

Diploma in Materials Management     : - Year 1988 form Mumbai University, India

LANGUAGE SPOKEN: -   Highly fluent in English both in written and oral communication.

Subject Matter Expertise

Services

Research
Consulting

Research Feasibility Study

Consulting Scientific and Technical Consulting

Work Experience

PRINCIPAL PHARMA CONSULTANT

Free lance

January 2020 - Present

PRINCIPAL PHARMA CONSULTANT

FREELANCER PHARMA CONSULTANT

January 2020 - Present

ASSOCIATE VICE PRESIDENT CORPORATE QUALITY

OTSUKA PHARMACEUTICAL INDIA

October 2014 - December 2019

HEAD QUALITY OPERATIONS

AZBIL TELSTAR (formerly Telstar Life Sciences)

May 2008 - September 2014

HEAD QUALITY

INDIAN IMMUNOLOGICALS LIMITED

July 2005 - April 2008

Education

POST GRADUATE IN SCIENCE - MICROBIOLOGY

S.P. UNIVERSITY, INDIA

August 1984 - May 1986

Certifications

Certification details not provided.